Obeticholic acid as a tablet is in clinical development for the treatment of advanced liver fibrosis due to non-alcoholic steatohepatitis (NASH). Non-alcoholic fatty liver disease (NAFLD) is the general term for conditions in which an excessive amount of fat is stored in the liver, but where this excess is not caused by heavy alcohol use. A build-up of fat alone is called simple fatty liver (steatosis). NASH occurs when the presence of fat leads to liver cell damage and inflammation (hepatitis). Over time, liver cell damage and inflammation due to NASH can cause scarring (fibrosis) of the liver which may increase until advanced. Once there is advanced fibrosis due to NASH, there is a higher risk of progression to cirrhosis and its complications such as liver failure, liver cancer, and death. Although simple fatty liver, NASH, and advanced fibrosis due to NASH are distinct types of NAFLD in terms of the risk to health they pose, they are considered stages of the same disease through which people will progress if lifestyle interventions are not effective.
Ustekinumab is a drug which is given as an injection and works by blocking the molecules that are involved in the inflammation which occurs in UC. Ustekinumab is already licenced for use in people with Crohn’s disease, which is another type of IBD. If ustekinumab is licenced this would provide another treatment option for people with moderate to severe active UC.